# Advancing a Candidate Polyclonal Antibody Therapy for Hantavirus Disease

> **NIH NIH R01** · GENEVA FOUNDATION · 2021 · $379,859

## Abstract

PROJECT SUMMARY/ABSTRACT
Hantaviruses are the etiological agents of hantavirus pulmonary syndrome (HPS) and hemorrhagic fever with
renal syndrome (HFRS). There are no FDA-approved medical countermeasures to prevent or treat these
unpredictable zoonotic diseases. Recently, clinicians in Chile demonstrated that convalescent plasma from
HPS survivors provided a clinical benefit in HPS patients in a compassionate-use study. However, the paucity
of available human plasma containing high-titer neutralizing antibodies against hantaviruses, and other
drawbacks to the use of human plasma derived products, makes the use of convalescent plasma as an anti-
hantavirus product untenable. We propose to further develop a potent polyclonal antibody anti-hantavirus
product using transchromosomal (Tc) bovine technology. This technology overcomes the significant challenges
presented by therapies consisting of polyclonal antibodies obtained from human plasma donors or animal
sources. SAB’s diversitAb™ platform technology uses cattle carrying knockouts of key bovine antibody heavy
light chains genes, and the addition of a Human Artificial Chromosome containing the entire human heavy
chain locus and the entire human kappa light chain locus. As partners, SAB and the US Army Medical
Research Institute of Infectious Diseases (USAMRIID) have already demonstrated that fully-human IgG
purified from plasma collected from the Tc bovines immunized with hantavirus DNA vaccines has potent
neutralizing antibody activity in vitro, and is protective in vivo (i.e., Syrian hamster models of lethal HPS
disease). Here, we will use our existing hantavirus DNA vaccines and diversitAb™ platform technology to
produce a pan-hantavirus polyclonal antibody product under cGMP. We will conduct in vitro neutralization
assays to measure potency, and in vivo efficacy studies using established Syrian hamster models of infection
and disease. In addition, we will subject the candidate product to stability testing, human tissue cross reactivity
testing, pharmacokinetic analysis in nonhuman primates, and a GLP preclinical toxicity study in rabbits. Our
goal is to advance a lead candidate anti-hantavirus polyclonal antibody immunotherapeutic product through
preclinical testing. At the conclusion of these IND-enabling studies, this candidate anti-hantavirus product will
be ready for a Phase 1 clinical trial.

## Key facts

- **NIH application ID:** 10211120
- **Project number:** 5R01AI132313-05
- **Recipient organization:** GENEVA FOUNDATION
- **Principal Investigator:** Jay Williams Hooper
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $379,859
- **Award type:** 5
- **Project period:** 2017-08-18 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10211120

## Citation

> US National Institutes of Health, RePORTER application 10211120, Advancing a Candidate Polyclonal Antibody Therapy for Hantavirus Disease (5R01AI132313-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10211120. Licensed CC0.

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